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Rapid determination of the anti-cancer drug Melphalan (AlkeranTM) in human serum and plasma by automated solid phase extraction and liquid chromatography tandem mass spectrometry

Davies, I. D., Allanson, J. P., Causon, R. C.
Chromatographia 2000 v.52 no.Supplement 1 pp. S92
antineoplastic agents, bias, blood serum, humans, ionization, liquid-liquid extraction, monitoring, pharmacokinetics, precision, reversed-phase liquid chromatography, solid phase extraction, tandem mass spectrometry
A bioanalytical method for the determination of the anticancer drug Melphalan (Alkeranᵀᴹ) in human serum and plasma is described. Automated solid phase extraction of the analyte is carried out with C18 sorbent packed in a 96 well format microtitre plate using a robotic sample processor. The extracts are analysed by isocratic reversed phase liquid chromatography using pneumatically and thermally assisted electrospray ionisation (TurbolonSprayᵀᴹ) with selected reaction monitoring. The method is specific and sensitive, with a range of 2–400 ng mL⁻¹ in human serum and plasma for Melphalan (sample volume 200 μl). The method is accurate and precise with intra-assay and inter-assay precision (%CV) of <15% and bias <15%. The automated extraction procedure is significantly faster than manual sample pretreatment methods: a batch of 96 samples is extracted in 50 minutes, allowing for faster sample turnaround. The method has been used to provide pharmacokinetic support to biocomparability studies of Alkeranᵀᴹ following single doses of oral tablet formulations.